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Technical File Documentation
Let KD&A help you with the development of Technical File Documentation that complies with the medical device regulations
Technical File documentation is a requirement for all medical device and IVD products – KD&A, as an expert medical device consultant, can assist you with the development of the Technical File for your device that complies with the applicable medical device regulations.
For all medical device and IVD manufacturers, a key component of gaining regulatory certification is the Technical File. This documentation, also known as a Technical File or Design Dossier, incorporates a large amount of product information and can be time consuming and difficult to compile. The Technical File describes your device and records on how your organisation demonstrates compliance with applicable regulatory requirements.
Technical File documentation created by KD&A is developed in line with the latest internationally acknowledged standards, guidelines and common specifications. We provide documentation to meet regulatory requirements for any target market, in particular:
- Australia
- EU
KD&A will create high quality Technical File for your product(s). One that complies with the applicable medical device regulations, standards, industry guidelines and common specifications. Our experience, once again, will help your company with a smooth journey through this aspect of the medical device and IVD regulatory process.
We pride ourselves on providing excellent
customer service to our clients

Cyclomedica Australia Pty Ltd
In the 2.5 years we have been working together, no task or challenge is too small or too big. They take both extremes with enthusiasm and ownership not often seen with other consultants. In fact, we don’t see them as consultants, they are an integral part of our team.
James McBrayer,
Managing Director & CEO, Cyclomedica Australia Pty Ltd

CT Healthcare
We have found KD&A’s service, support and understanding invaluable in helping to guide our business through different situations that have arisen. Their work has been done in an extremely professional, efficient and prompt manner, which has been important in situations where immediate action has been needed.
Sean Crealey,
Director of Operations, CT Healthcare

SPD Development Company Ltd
In the 5 years we have been working together, we have found KD&A to be helpful, knowledgeable and always professional. Their ability to provide clear, accurate and timely responses to regulatory enquiries has been valuable to our business.
Graham Howard,
Regulatory Affairs Manager, SPD Development Company

PainChek
We have found KD&A’s services to be solution driven, the team is professional and efficient. I highly recommend KD&A regulatory services and expertise.
Philip Daffas,
CEO, PainChek

Bodyflow International Pty Ltd
“KD&A provided Bodyflow with professional, informative and relevant regulatory advice. In addition, the workshop I attended (held by KD&A along with two other regulatory consultants) allowed for interactive learning – growing my understanding of the requirements for our medical device.”
Dean Libertone,
Compliance Officer, Bodyflow International Pty Ltd

Elastagen Pty Ltd
“KD&A have provided invaluable quality management system and regulatory support as Elastagen has successfully transitioned from an R&D organisation to a clinical stage medical device company operating in compliance with ISO 13485 & 21CFR820. KD&A have been by our side from day 1 and are always available to help with any of our regulatory questions.”
Orsola Regaglia,
Operations Manager, Elastagen Pty Ltd

Opto Global Pty Ltd
“KD&A have been providing Opto global with high quality and professional assistance for 5 years. Their service is delivered efficiently, thoroughly and within the required timeframe.”
Medhat Eldeeb,
Regional Sales Manager, Opto Global Pty Ltd

Signostics Ltd
“We have used KD&A’s services since our inception. Initially, KD&A managed the creation of our quality system, which they implemented quickly and efficiently. Since the initial engagement we have grown and employed quality and regulatory managers, with KD&A continuing to provide quality management and regulatory affairs advice. They have always been responsive and totally professional in their approach and dealings. We have no hesitation in recommending them.”
Stewart Bartlett,
COO, Signostics Ltd

Australian Dental Manufacturing Pty Ltd
“We could not help but come away with respect for, and impressed with, the service KD&A provided to our company. I would not hesitate in recommending KDA to anyone who needs to deal with TGA regulatory requirements.”
Dr. Matthew Athanassiadis,
Director, Australian Dental Manufacturing Pty Ltd
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